DEEP Ablation for Atrial Fibrillation
(DEEP Trial)

Recruiting in Palo Alto (17 mi)

+16 other locations

Overseen ByVigneshwar Kasirajan, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: AtriCure, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?The objective of this study is to establish the safety and effectiveness of a dual epicardial and endocardial ablation procedure for patients presenting with Persistent Atrial Fibrillation or Longstanding Persistent Atrial Fibrillation

Eligibility Criteria

This trial is for patients with Persistent or Longstanding Persistent Atrial Fibrillation who haven't responded to certain heart rhythm medications. It's not suitable for individuals with a BMI over 40, recent thromboembolism, severe clotting disorders, risks from general anesthesia or surgery, drug/alcohol abuse, psychological issues affecting consent and follow-up, specific heart conditions like severe valve disease or CAD needing intervention, extreme pulmonary issues, or those treated for arrhythmias other than AF.

Inclusion Criteria

My heart condition hasn't improved despite taking specific heart rhythm medications.

Exclusion Criteria

A condition that, in the opinion of the investigator, may jeopardize the patient's well-being and/or the soundness of this clinical study

You have a blood clot in a specific part of your heart, as seen on an ultrasound test.

I have had complications from a heart procedure, including heart lining issues.

+25 more

Participant Groups

The study tests the safety and effectiveness of combining two procedures—AtriCure Bipolar System (epicardial ablation) and Endocardial Ablation—for treating persistent types of atrial fibrillation that don't respond well to medication. The goal is to see if this dual approach can better manage irregular heartbeats.

1Treatment groups

Experimental Treatment

Group I: AtriCure Bipolar System and AtriClip® PRO LAA Exclusion SystemExperimental Treatment1 Intervention

AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System at day 1 of surgical procedure followed by endocardial catheter ablation procedure to occur at approximately 90 days after day 1 of surgical procedure.